Safety and Pharmacokinetics Study of a New Drug for Type 2 Diabetes

April 18, 2016 updated by: Genmedica Therapeutics S.L.

A Double-Blind, Placebo-Controlled, Randomised, Two Part Study of the Safety and Pharmacokinetics of GMC-252 in A) Healthy Male Subjects, Including a Comparison of GMC-252 Dosing in the Fed and Fasted States ,and B) in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of GMC-252-L-Lysine Salt in healthy male subjects.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Merthyr Tydfil, United Kingdom, CF48 4DR
        • Simbec Research Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Body Mass Index (BMI) within the range of 18-35 kg/m2 inclusive. BMI = Body weight (kg) / [Height (m)]2.
  • Diet: Able to eat standard food, no vegetarians.
  • Compliance: Understood and was willing, able and likely to comply with all study procedures and restrictions.
  • Consent: Demonstrated understanding of the study and willingness to participate as evidenced by voluntary written informed consent and had received a signed and dated copy of the Informed Consent Form.
  • Had no known hypersensitivity to diflunisal, NAC (N-acetylcysteine) or other non-steroidal anti-inflammatory drugs (NSAIDs).
  • Had no known peptic ulcer diseases.
  • Had an estimated creatinine (CREA) clearance ≥ 50 mL/min (Creatinine clearance was calculated from the serum CREA value using the Cockroft & Gault formula).
  • Had no history of heart failure or uncontrolled hypertension or other known overt cardiovascular disease.
  • Had no history of 'Aspirin Triad' (chronic rhinosinusitis with polyps, severe asthma and intolerance to aspirin or other NSAIDs).
  • Had no marked abnormality of liver tests before entry into the study.
  • Male subject willing to use an effective method of contraception, if applicable (unless anatomically sterile or where abstaining from sexual intercourse was in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months afterwards.
  • Subject with no clinically significant abnormal serum biochemistry, haematology and urine examination values at the Screening Visit.
  • Subject with a negative urinary drugs of abuse screen (a positive alcohol result could have been repeated at the discretion of the Investigator).
  • Subject with negative human immunodeficiency virus (HIV) and Hepatitis B (Hep B) and Hepatitis C (Hep C) results.
  • Subject with no clinically significant abnormalities in 12-lead ECG at the Screening Visit.
  • Subject was available to complete the study (including all Follow-up Visits).
  • Subject satisfied a medical examiner about their fitness to participate in the study.
  • Subjects were non-smokers and non-alcohol drinkers or drank alcohol in moderation (e.g. ≤ 14 units/week).

Exclusion Criteria:

  • A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
  • Receipt of regular medication at the Screening Visit that may have had an impact on the safety and objectives of the study (at the Investigator's discretion).
  • Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
  • A clinically significant history of previous allergy/sensitivity to GMC-252.
  • A clinically significant history of drug or alcohol abuse.
  • Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
  • Participation in a New Chemical Entity clinical study within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks. (N.B. washout period between trials defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
  • Donation of 450 mL or more blood within the previous 12 weeks.
  • Receipt of any medication since the Screening Visit that may have had an impact on the safety and objectives of the study (at the Investigator's discretion).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A (Part A)

Single ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo

Interventions:

Drug: GMC-252-L-Lysine Other: Placebo

Experimental: Cohort B (Part A)

Single ascending oral administrations of GMC-252-L-Lysine Salt and matching placebo

Interventions:

Drug: GMC-252-L-Lysine Other: Placebo

The dose administered in Part A (fed) was based on the outcome of Part A (fasted).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: Over a 14 days period post dose
Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry)
Over a 14 days period post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximal Concentration (Cmax)
Time Frame: Over a 14 days period post dose
Over a 14 days period post dose
Area Under the Concentration-Time Curve
Time Frame: Over a 14 days period post dose
Over a 14 days period post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Salvatore Febbraro, MBBS, Simbec Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 15, 2016

First Posted (Estimate)

February 19, 2016

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • GMC-252-1.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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